Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 1 Diabetes Mellitus

Interventions: Drug: HOE901-U300 (Insulin glargine new formulation)
Drug: Lantus (Insulin glargine)

Registration Number: NCT01683266

Lead Sponsor: Sanofi

Brief Summary: Primary Objective:

* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:

* Change of HbA1c from baseline to endpoint (scheduled Month 6)

* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)

* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)

* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)

* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

Detailed Description: The maximum study duration was up to approximately 54 weeks per participants:

* Up to 2-week screening period

* 6-month open-label comparative efficacy and safety treatment period

* 6-month open-label comparative safety extension period

* 48-hour post-treatment safety follow-up period

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 549

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HOE901-U300	HOE901-U300 (Insulin glargine new formulation)	HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).
Lantus	Lantus (Insulin glargine)	Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Primary Outcome Measures

Name	Time	Method
Change In HbA1c From Baseline to Month 6 Endpoint	Baseline, Month 6

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint	Month 6
Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint	Baseline, Month 6	DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.
Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint	Baseline, Month 6	Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6	Month 6
Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint	Baseline, Month 6	Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.
Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint	Baseline, Month 6
Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint	Baseline, Month 6	Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.
Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint	Baseline, Month 6
Percentage of Participants With HbA1c <7% at Month 6 Endpoint	Month 6
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12	Up to Month 12	Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L).
Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint	Month 6

Trial Locations

Locations (147): Investigational Site Number 840156
🇺🇸
Chandler, Arizona, United States
Investigational Site Number 840177
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Little Rock, Arkansas, United States
Investigational Site Number 840430
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Bell Gardens, California, United States
Investigational Site Number 840131
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Escondido, California, United States
Investigational Site Number 840140
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Fresno, California, United States
Investigational Site Number 840107
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Greenbrae, California, United States
Investigational Site Number 840149
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Huntington Beach, California, United States
Investigational Site Number 840120
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La Jolla, California, United States
Investigational Site Number 840123
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La Mesa, California, United States
Investigational Site Number 840159
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La Mesa, California, United States
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Investigational Site Number 840156
🇺🇸Chandler, Arizona, United States